Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

Tooth Loss Clinical Trial

Official title:

Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04605016
• Other study ID #: PI04791-2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. It is a randomized clinical trial, in which participants will be randomly allocated to two groups: test group (implants with hydrophilic surface) and control group (implants with hydrophobic surface). The null hypothesis is that the implant stability quotient of hydrophilic and hydrophobic dental implants show a similar progression after placement in posterior tooth gaps.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 30, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Present single or multiple intercalated untreated tooth gaps in the posterior region of the mandible or maxilla;

• Agree to participate in the study by signing the informed consent form.

Exclusion Criteria:

• Unavailability for participation or signs that they could not comply with the schedule of follow-up visits;

• Presence of general and/or local contraindications that could prevent the surgical procedure for implant placement;

• Presence of conditions that may interfere with the prognosis, such as current treatment with bisphosphonates or report of use for less than 2 years, presence of rheumatic diseases, among others;

• Absence of the minimum bone quantity of 8 mm in length and 3.75 mm in diameter for installation of an implant in the tooth gap;

• Absence of a mesio-distal space of at least 4.6 mm in the single tooth gap required to place the surgical guide;

• Do not present a mouth opening of at least 12mm required for the proper of the guided surgical kit together with the surgical guide;

• Do not present a band of keratinized tissue favorable for maintaining peri-implant health.

• Present motor difficulties that compromise adequate oral hygiene.

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Device:
• Hydrophilic surface implants
A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
• Hydrophobic surface implants
A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.

Locations

Country	Name	City	State
Brazil	Faculty of Dentistry of the Federal University of Goias	Goiania	Goias

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of implant stability	Implant stability was set as the primary outcome. The implant stability quotient (ISQ) will be measured using a portable device called Osstell ISQ (Osstell Mentor, Integration Diagnostics, Göteborg, Sweden).	10 time-points will be considered and divided in two phases: surgical and prosthetic. The last measure will occur 1 year after the placement of the definitive implant restoration.
Secondary	Implant success	Each implant will be assessed according to the health scale of the International Congress of Oral Implantologists (ICOI-Pisa health scale). After clinical assessment, each implant will be classified as 'success', 'satisfactory survival', 'compromised survival' or 'failure'.	Assessed at the 12-month follow-up visit.
Secondary	Periimplant bone level	Periapical radiographs will be obtained and the periimplant bone level will be measured and compared longitudinally.	Radiographs will be obtained at 4 time points: immediately after implant placement, at the session of the provisional prosthesis installation, and at the 6 and 12-month follow-up visits after the delivery of the definitive prosthesis.
Secondary	Condition of the periimplant soft tissues	The following parameters will be assessed clinically: presence/absence of bleeding on probing, probing depth, and presence/absence suppuration.	15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.